A Comparative Study of Salvage Treatment With Combination of Docetaxel and Epirubicin

NCT ID: NCT01624025

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-02-29

Brief Summary

A salvage treatment with combination of docetaxel and epirubicin in patients with unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based study

Conditions

Metastatic Advanced Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HER2 positive

Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks)

Group Type: EXPERIMENTAL

Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks

Intervention Type: OTHER

Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.

HER2 negative

Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.

(Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks)

Group Type: ACTIVE_COMPARATOR

Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks

Intervention Type: OTHER

Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.

Interventions

Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks

Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed metastatic, or recurrent AGC

2. Previous use of fluoropyrimidine as palliative chemotherapy. Concurrent use of platinum is permitted. Patient with recurred disease within 6 months after the end of adjuvant therapy can participate to this trial.

3. Documented HER2 expression status.

4. Radiologically proven progression of disease.

5. Age > 20 years

6. ECOG PS 0 - 2

7. Life expectancy more than 3 months

8. Adequate organ function for treatment including liver, kidney and bone marrow (absolute neutrophil count (ANC) ≥ 1,500/ul, platelets ≥ 100,000/ul, AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement, Total serum bilirubin ≤ 2.0 mg/dL)

9. Written informed consent

Exclusion Criteria

1. Prior administration of taxane or anthracycline as palliative chemotherapy. If those agents were used as adjuvant or neoadjuvant aim, at least 6 months should be passed.

2. Uncontrolled medical comorbidities Congestive heart failure (NYHA class III or IV) Recent (within 6 months) unstable angina or myocardial infarct Clinically significant cardiac arrhythmia LVEF < 45% Liver cirrhosis (Child-Pugh class B or C) Interstitial pneumonia Psychiatric illness/social situations that would limit compliance with study requirements

3. Active CNS metastasis not controllable with radiation or steroid

4. Concurrent administration of systemic chemotherapy or radiotherapy. Palliative radiotherapy for pain control more than 2 weeks ago is acceptable.

5. Pregnant or lactating women.

6. Peripheral neuropathy G3~4.

7. Metachronous malignancy other than adequately treated CIN of uterine cervix, basal cell or squamous cell carcinoma of the skin.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei University College of Medicine

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2012-0222

Identifier Type: -

Identifier Source: org_study_id